10 Questions to Ask Your Testing Lab in Light of FDA's Alert on Fraudulent and Unreliable Data
10 Questions to Ask Your Testing Lab in Light of FDA's Alert on Fraudulent and Unreliable Data
The FDA just warned of an increase in unreliable test data submitted by medical device manufacturers from third-party labs. Here are some questions your lab ought to be answering.
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As reported in a new letter to industry, the FDA has identified an increase in fraudulent and unreliable laboratory testing data in premarket submissions.
It reminds sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting them to the FDA.
The FDA’s letter, at a glance
We know your time is short, so here’s what you need to know from FDA’s letter:
Rising concerns over data integrity: The FDA has observed an increasing number of instances where testing data submitted by medical device manufacturers, generated by third-party test labs, have been fabricated, duplicated from other device submissions, or are otherwise unreliable. This trend is particularly noted in labs based in China and India.
Impact on regulatory decisions: The submission of unreliable data has led to the FDA being unable to rely on such data to grant marketing authorization for medical devices. This results in delays or rejections of device approvals, directly impacting device firms and leading to reduced access to new medical devices for patients and healthcare providers.
Expectations from device firms: The FDA expects medical device firms to carefully evaluate third-party labs they engage for performance testing and to independently verify all testing results before submission. Firms are responsible for ensuring that the data submitted are truthful, accurate, and not copied from unrelated submissions.
Guidance on third-party lab engagement: Device firms are urged to qualify third-party labs diligently, scrutinize testing data, and identify any results that are improbable or inconsistent with known information about the device. Firms should also consider partnering with labs voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, although this does not replace the need for independent data assessment.
FDA's actions to address data integrity violations: The FDA is pursuing various actions to identify and confront data integrity violations, including through its Bioresearch Monitoring Program.
The announcement emphasizes the need for the medical device industry to ensure the integrity of all data submitted to the FDA, protect patients and healthcare providers, and ensure access to safe, effective, and high-quality medical devices.
Our analysis
The FDA's announcement underscores a series of critical takeaways and expert insights into the medical device industry's practices, particularly regarding the use of third-party laboratories for device testing:
Step up your due diligence. This means not only verifying the labs' credentials but also understanding their testing methodologies and ensuring they have a robust quality control system in place. Review their inspection history for 483s and warning letters. Notable fabrication and duplication of data suggest a need for a higher level of scrutiny than what might have previously been the norm.
Quality over cost. We hope this prompts a reevaluation of the criteria used by device firms when selecting third-party labs. We always advise against choosing labs solely based on cost considerations. The cheapest option may not always provide the rigorous testing and reliable data required for FDA approval. Even if more expensive up front, investing in quality testing can prevent costly delays or rejections by the FDA later, which are almost always more expensive. Whenever possible, work with labs accredited under frameworks recognized for high standards, such as the Accreditation Scheme for Conformity Assessment (ASCA) program, and have a history of compliance and integrity.
Independently verify labs’ data. There's a strong call for independent verification of all third-party testing data before submission to the FDA. Here are our specific recommendations:
Require third-party labs to sign data integrity agreements that outline the expectations and requirements for data generation, recording, and reporting, including adherence to recognized standards and regulations. If they refuse, red flag.
Develop a process for independently verifying critical data points received from third-party labs. This could involve re-testing samples in-house or using another third-party lab for confirmation.
Insist on comprehensive documentation for all tests and analyses, including raw data, methodologies used, and detailed reports. This documentation should allow for complete traceability from the raw data to the final reported results.